Product code JAD— Radiology
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
- Classification name
- System, Therapeutic, X-Ray
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Total cleared
- 53
- First cleared
- Most recent
Market context for product code JAD
FDA has cleared devices under product code JAD between 1978 and 2025, filed by 33 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2023
- 2022
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2009
- 2008
- 2007
Top applicants under product code JAD
Recent clearances under product code JAD
- K250692 — GentleBeam (GB1000)
- K241174 — INTRABEAM (700) +1 more
- K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
- K213942 — Esteya
- K182641 — Sensus IORT System
- K190255 — Sensus Healthcare TVM Balloon Applicator
- K173425 — SRT-100+
- K172080 — Photoelectric Therapy System
- K162568 — INTRABEAM 600
- K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200
- K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
- K141343 — AXXENT CERVICAL APPLICATOR
- K132092 — ESTEYA
- K131582 — SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
- K130549 — INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
- K123985 — SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
- K122951 — XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
- K121653 — INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
- K110590 — INTRABEAM NEEDLE APPLICATOR
- K111299 — AXXENT RADIATION SHIELD - RIGID
- K090584 — INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
- K090914 — AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
- K083734 — AXXENT SURFACE APPLICATOR, MODEL 710257
- K072616 — AXXENT VAGINAL APPLICATOR
- K072683 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
- K063456 — SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
- K050843 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
- K051055 — INTRABEAM SYSTEM
- K992577 — PHOTON RADIOSURGERY SYSTEM (PRS)
- K980526 — PHOTON RADIOSURGERY SYSTEM PRS400
- K973315 — THERAPAX DXT 300 MODEL HF-300
- K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-705
- K964947 — PHOTON RADIOSURGERY SYSTEM (PRS)
- K971074 — THERAPAX SXT 150
- K962613 — DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
- K935209 — INSTA-FLO
- K923584 — THERAPAX DXT 300 SERIES 3
- K904005 — HUESTIS FLEXI-BOARD
- K903377 — COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
- K894683 — FABFOAM #302
- K882484 — CMS RECORD AND VERIFY SYSTEM
- K874214 — S9 DISPLAY SYSTEM
- K871810 — PLAN-32 SOFTWARE
- K861431 — THERAPAX HT 150T
- K854609 — MEVAMATIC 3
- K844424 — INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
- K833560 — RTP-5100-5200-5300 & 5400
- K813439 — RTP-5000
- K811528 — RADIATION BOLUS
- K781084 — THERAPAX 150A
- K780278 — RADIATION THERAPY TREAT. PLAN. SYS.
- K780157 — RADIATION TREATMENT PLANNING SYSTEM
- K771817 — EMI THERAPY SIMULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.